ClinicalTrials.gg
RecruitingNCT06386146Updated May 22, 2026

JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation

A Phase 1/2 interventional study of JAB-30355 and JAB-30355 in Solid Tumors, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.

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Phase
Phase 1/2
Study type
Interventional
Enrollment
144
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 392 studies in Ovarian Neoplasms with a site in China — 198 open to participants now, 231 under way, 35 of them phase 3. Ovarian Neoplasms · China.

Planned enrollment
111th of 319
144 · median 83
Started
2024
with 53 others
Phase 1/2
53 of 392
32 open now
Primary completion
2027-01
later than 114 of 230 live
Registered
252nd of 392
by date

Among the 392 studies in Ovarian Neoplasms with a site in China, this one is the 111th largest by planned enrollment of the 319 interventional ones that give a count, is one of 54 that started in 2024, is one of 53 in phase 1/2, reaches primary completion later than 114 of the 230 other live ones, and was the 252nd registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

198 of the 392 studies in Ovarian Neoplasms with a site in China are open now. Recruiting first, the newest first:

193 more — sign in →

All 198 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.

Read the detailed description

This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.

03

Conditions studied

  • Solid Tumors

Browse trials for

Keywords

  • TP53 Y220C reactivator; TP53 Y220C mutation; P53; Tumor protein p53; TP53; Advanced solid tumors; Ovarian Cancer; JAB-30355
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written .
  • Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
  • performance status score of 0 or 1.
  • Has been treated with at least one for that tumor type and stage.
  • Have documentation of confirmed TP53 Y220C mutation.
  • At least 1 per v1.1.
  • Adequate hematological, renal and hepatic function and appropriate coagulation condition.
  • Able to swallow and retain orally administered medication.

Exclusion criteria

Exclusion Criteria:

  • Active brain or spinal or primary CNS tumor.
  • Active infection requiring systemic treatment within 7 days.
  • Active or .
  • Any severe and/or uncontrolled medical conditions.
  • ≤50% assessed by ECHO or MUGA.
  • > 470 msec.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Dose escalation phase

    Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD)

    Drug: JAB-30355

  • Experimental
    Dose expansion phase

    Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level.

    Drug: JAB-30355

Interventions

  • DrugJAB-30355

    Oral administration

  • DrugJAB-30355

    Oral administration

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Number and proportion of participants who experience at least one dose limiting toxicity (DLT)

    Time frame: Approximately one year

  2. Number of participants with adverse events

    All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.

    Time frame: Approximately three years

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.

    Time frame: Approximately three years

  2. Time to reach the observed maximum (peak) concentration (Tmax)

    Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.

    Time frame: Approximately three years

  3. Terminal half-life (t1/2)

    Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.

    Time frame: Approximately three years

  4. Objective response rate (ORR)

    ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Time frame: Approximately three years

  5. Duration of response (DOR)

    DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1.

    Time frame: Approximately three years

07

Study locations

13 of 15 sites recruiting
  • Research Site
    Denver, Colorado 80218, United States
    Recruiting
  • Research site
    Lake Mary, Florida 32771, United States
    Terminated

    Not enrolling at this site.

  • Research site
    St Louis, Missouri 63110, United States
    Recruiting
  • Research site
    Canton, Ohio 44718, United States
    Terminated

    Not enrolling at this site.

  • Research site
    Cleveland, Ohio 44195, United States
    Recruiting
  • Research Site
    Nashville, Tennessee 37203, United States
    Recruiting
  • Research site
    Houston, Texas 77030, United States
    Recruiting
  • Research Site
    Beijing, Beijing Municipality 100000, China
    Recruiting
  • Research Site
    Beijing, Beijing Municipality 100021, China
    Recruiting
  • Research Site
    Beijing, Beijing Municipality 100142, China
    Recruiting
  • Research Site
    Guangzhou, Guangdong 510000, China
    Recruiting
  • Research Site
    Zhengzhou, Henan 451191, China
    Recruiting
  • Research Site
    Shenyang, Liaoning 110801, China
    Recruiting
  • Research Site
    Jinan, Shandong 250117, China
    Recruiting
  • Research Site
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Jan 2027, 30 months after the start.

Of 116 industry-sponsored phase 1/2 interventional studies under Ovarian Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 88. This study's planned 30 months is below that.

Counting every sponsor, half of 173 studies reached it within 65 months; a quarter within 44 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2024
First posted
Apr 26, 2024
StartActual
Jul 24, 2024
Primary completionEst.
Jan 2027
CompletionEst.
Jul 2027
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06386146
Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Apr 26, 2024
Start date
Jul 24, 2024
Primary completion
Jan 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
May 22, 2026

Study contacts

Jacobio Pharmaceuticals
Contact
clinicaltrials@jacobiopharma.com
781-918-6670

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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